ffbf7b47-219f-4f9d-ab51-29e29cde84bbUpdatePublished32019-10-072018-03-26In Commercial Distribution04540778169593PrimaryGS1OTW TAKERUDC-PY3520UA2DC-PY3520UA2690535406KANEKA CORPORATION1OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm). falsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse800-888-3786tmccustomer.admin@terumomedical.comK17226400047732Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.falseActiveLOXCatheters, Transluminal Coronary Angioplasty, PercutaneousDevice Size Text, specifyMaximum Guidewire Diameter; 0.014 inchDevice Size Text, specifyCompatible Guiding Catheter; 5 FrDevice Size Text, specifyRated Burst Pressure; 14 atmDevice Size Text, specifyNominal Pressure; 6 atmDevice Size Text, specifyProximal Shaft Diameter; 3.3 FrDevice Size Text, specifyDistal Shaft Diameter; 2.7 FrDevice Size Text, specifyCatheter Working Length; 1450 mmDevice Size Text, specifyBalloon Length; 20 mmDevice Size Text, specifyBalloon Diameter; 3.5 mmSpecial Storage Condition, SpecifyStore in a cool, dry, dark place. Avoid exposure to water, direct sunlight.truefalse